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PD-L1/TGFbetaRII Inhibitor

Anti-PD-L1/TGFbetaRII Fusion Protein M7824 for Rectal Cancer

Phase 1 & 2
Waitlist Available
Led By Van K Morris
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer immunotherapy to see if it can shrink tumors or help other treatments work better.

Eligible Conditions
  • Rectal Cancer
  • Colon Cancer
  • Cancer
  • Lynch syndrome
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clearance of circulating tumor DNA (cohort D)
Objective Response Rate (ORR)
Secondary study objectives
Adverse Events of Treatment with M7824
Disease-Free Survival (DFS) - cohort D only
Progression-Free Survival (PFS)

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (M7824)Experimental Treatment1 Intervention
Patients receive M7824 IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity (Cohorts A,B, and C) or for six doses in patients with detectable circulating tumor DNA (ctDNA) following resection of all known liver metastases (Cohort D).

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,927 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,171 Total Patients Enrolled
Van K MorrisPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,530 Total Patients Enrolled
~10 spots leftby Nov 2025
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